Melatonin Versus Placebo for Bipolar Disorder
ConditionBipolar Affective Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLars Vedel Kessing
About this trial
The objective with this study is to conduct a 6-month RCT comparing effects of add-on melatonin versus add-on placebo on mood stabilisation and other critical patient outcomes in patients with BD and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse
Eligibility criteria
Qualifiers
Bipolar disorder with diagnosis confirmed by SCAN interview
Age 18 - 70 years
The participants must be able to read and understand the participant information in their native language and consent (English and Danish)
Habile (i.e able to give informed consent)
Disqualifiers
Past intolerance to melatonin (allergic reactions)
Impaired renal or hepatic function (defined by GFR <60 ml/min and/or ALAT over allowed reference value)
Women who are pregnant, breastfeeding or planning pregnancy in near future.
Trial design
Treatments tested in this trial
- Melatonin
- Placebo
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lars Vedel Kessing
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor institution
Source ClinicalTrials.gov